Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020011
Company: ABBVIE ENDOCRINE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
LUPRON DEPOT LEUPROLIDE ACETATE 3.75MG INJECTABLE;INJECTION Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/22/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2013 SUPPL-41 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020708Orig1s034,019943Orig1s034,020011Orig1s041,203696Orig1s001ltr.pdf
01/23/2012 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019943s033,020011s040ltr.pdf
06/14/2011 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019943s032,020011s039ltr.pdf
03/28/2012 SUPPL-38 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020708s031,019943s031,020011s038ltr.pdf
10/29/2010 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019943s030,020011s037ltr.pdf
06/02/2009 SUPPL-36 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019943s029,020011s036ltr.pdf
10/31/2007 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019943s026, 020011s033, 020708s026ltr.pdf
09/15/2005 SUPPL-31 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf
09/15/2005 SUPPL-29 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/0197322729190103119943222420517181920708202120011tr.pdf
01/12/2004 SUPPL-28 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19732s026,19943s021,20011s028,20517s016,20708s018ltr.pdf
09/20/2002 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/2004 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19943slr018,20011slr025,20708slr015ltr.pdf
05/23/2002 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/21/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

11/14/2001 SUPPL-22 Labeling

Label is not available on this site.

09/21/2001 SUPPL-21 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20011s21ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-011S021_Lupron.cfm
03/01/2001 SUPPL-20 Labeling

Label is not available on this site.

01/24/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/30/1998 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

04/09/1998 SUPPL-14 Efficacy-New Indication Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-S014_LUPRON_APPROV.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20011-s014_Lupron.cfm
06/27/1997 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1996 SUPPL-10 Labeling

Label is not available on this site.

08/11/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/22/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/26/1995 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1994 SUPPL-5 Labeling

Label is not available on this site.

11/07/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1994 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/26/1994 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2013 SUPPL-41 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020011s041lbl.pdf
03/28/2012 SUPPL-38 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019943s031,020011s038,020708s031lbl.pdf
01/23/2012 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020011s040lbl.pdf
06/14/2011 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019943s032,020011s039lbl.pdf
10/29/2010 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019943s030,020011s037lbl.pdf
06/02/2009 SUPPL-36 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019943s029,020011s036lbl.pdf
09/21/2001 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20011s21lbl.pdf

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